- Expert Insights on Clinical Relevance and Scientific Rationale
- The replay of the event is available on the Investor Relations section of the Actuate website
CHICAGO and FORT WORTH, Texas, June 02, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ:ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced key takeaways from its Key Opinion Leader (KOL) event held on May 31, 2025 discussing the positive topline results from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
The study met its primary endpoint, demonstrating a clinically meaningful increase in median overall survival (mOS) of 10.1 months compared to 7.2 months (p = 0.01), with a 37% reduction in the risk of death (HR = 0.63). The elraglusib/GnP arm also doubled the 12-month survival rate in 44.1% of patients compared to GnP alone (22.3%), with a favorable safety profile.
The KOL event followed the presentation of topline trial data during an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting. The event featured a fireside discussion with leading mPDAC clinicians, all with direct participation in the elraglusib clinical trial program: Colin Weekes, MD, PhD, Massachusetts General Hospital; Devalingam Mahalingam, MD, Northwestern University Feinberg School of Medicine; Rachna Shroff, MD, MS, FASCO, University of Arizona Cancer Center; Tanios Bekaii-Saab, MD, FACP, Mayo Clinic College of Medicine and Science.
The panelists highlighted the implications of the Phase 2 Actuate 1801 Part 3B results in the broader context of the unmet need in mPDAC, the unique immune-modulating mechanism of elraglusib, and its potential to reshape the treatment landscape, as follows.